Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis
Abstract Background Allergen immunotherapy (AIT) is an approved treatment for seasonal respiratory allergic diseases. A depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy (SCIT) has been demonstrated to be efficacious and safe in patients allergic to birch pollen an...
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| Language: | English |
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Wiley
2022-10-01
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| Series: | Clinical and Translational Allergy |
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| Online Access: | https://doi.org/10.1002/clt2.12185 |
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| author | Natalija Novak Margitta Worm Petra Staubach Marek Jutel Angelika Sager Oliver Pfaar |
| author_facet | Natalija Novak Margitta Worm Petra Staubach Marek Jutel Angelika Sager Oliver Pfaar |
| author_sort | Natalija Novak |
| collection | DOAJ |
| description | Abstract Background Allergen immunotherapy (AIT) is an approved treatment for seasonal respiratory allergic diseases. A depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy (SCIT) has been demonstrated to be efficacious and safe in patients allergic to birch pollen and its homologous group. Objective To determine whether SCIT with a birch pollen formulation (5000 depigmented polymerized (DPP) units/mL) shows sustained and long‐term efficacy in adults and adolescents with birch‐pollen induced allergic rhinitis with or without intermittent asthma. Methods A multicentre (n = 66), double‐blind, placebo‐controlled Phase III clinical trial was performed in the Czech Republic, Finland, Germany, Latvia, Lithuania, Poland and Russia. Participants were randomized 2:1 to active treatment (birch 5000 DPP/ml) or placebo for three years of SCIT and followed up for two treatment‐free years. The primary efficacy endpoint was the EAACI's combined symptom and medication score for rhinoconjunctivitis (CSMSEAACI). Results A total of 973 participants were screened and 649 were randomized (active treatment: n = 434; placebo: n = 215). The intention‐to‐treat analysis of the CSMSEAACI in the overall study population did not demonstrate statistically significant differences in years 1, 2 and 3. In a post‐hoc analysis, among the subgroup of patients monosensitized to birch pollen allergen only (n = 200), we observed a statistically significant difference (active treatment vs. placebo) in the CSMSEAACI in year 2, 3 and 5. The AIT's safety profile was good. Conclusions SCIT with a depigmented polymerized birch pollen extract was safe. Sustained and long‐term efficacy in years 2, 3 and 5 in monosensitized patients, but not in polysensitized patients was demonstrated. (EudraCT 2012‐000414‐11) |
| first_indexed | 2024-04-11T22:57:05Z |
| format | Article |
| id | doaj.art-1f4702a84de8459fa95fdd4dc73c47b8 |
| institution | Directory Open Access Journal |
| issn | 2045-7022 |
| language | English |
| last_indexed | 2024-04-11T22:57:05Z |
| publishDate | 2022-10-01 |
| publisher | Wiley |
| record_format | Article |
| series | Clinical and Translational Allergy |
| spelling | doaj.art-1f4702a84de8459fa95fdd4dc73c47b82022-12-22T03:58:23ZengWileyClinical and Translational Allergy2045-70222022-10-011210n/an/a10.1002/clt2.12185Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitisNatalija Novak0Margitta Worm1Petra Staubach2Marek Jutel3Angelika Sager4Oliver Pfaar5Department of Dermatology and Allergology University of Bonn Medical Center Bonn GermanyDepartment of Dermatology Allergy and Venerology Division of Allergy and Immunology, Charité Universitätsmedizin Berlin GermanyDepartment of Dermatology University Medical Center of the Johannes Gutenberg University Mainz Mainz GermanyDepartment of Clinical Immunology Wroclaw Medical University Wroclaw PolandLETI Pharma GmbH Witten GermanyDepartment of Otorhinolaryngology Head and Neck Surgery Section of Rhinology and Allergy University Hospital Marburg Philipps‐Universität Marburg Marburg GermanyAbstract Background Allergen immunotherapy (AIT) is an approved treatment for seasonal respiratory allergic diseases. A depigmented polymerized birch pollen extract for subcutaneous allergen immunotherapy (SCIT) has been demonstrated to be efficacious and safe in patients allergic to birch pollen and its homologous group. Objective To determine whether SCIT with a birch pollen formulation (5000 depigmented polymerized (DPP) units/mL) shows sustained and long‐term efficacy in adults and adolescents with birch‐pollen induced allergic rhinitis with or without intermittent asthma. Methods A multicentre (n = 66), double‐blind, placebo‐controlled Phase III clinical trial was performed in the Czech Republic, Finland, Germany, Latvia, Lithuania, Poland and Russia. Participants were randomized 2:1 to active treatment (birch 5000 DPP/ml) or placebo for three years of SCIT and followed up for two treatment‐free years. The primary efficacy endpoint was the EAACI's combined symptom and medication score for rhinoconjunctivitis (CSMSEAACI). Results A total of 973 participants were screened and 649 were randomized (active treatment: n = 434; placebo: n = 215). The intention‐to‐treat analysis of the CSMSEAACI in the overall study population did not demonstrate statistically significant differences in years 1, 2 and 3. In a post‐hoc analysis, among the subgroup of patients monosensitized to birch pollen allergen only (n = 200), we observed a statistically significant difference (active treatment vs. placebo) in the CSMSEAACI in year 2, 3 and 5. The AIT's safety profile was good. Conclusions SCIT with a depigmented polymerized birch pollen extract was safe. Sustained and long‐term efficacy in years 2, 3 and 5 in monosensitized patients, but not in polysensitized patients was demonstrated. (EudraCT 2012‐000414‐11)https://doi.org/10.1002/clt2.12185allergic rhinitisbirch pollenlong‐termphase IIIpost‐treatmentsubcutaneous allergen immunotherapy |
| spellingShingle | Natalija Novak Margitta Worm Petra Staubach Marek Jutel Angelika Sager Oliver Pfaar Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis Clinical and Translational Allergy allergic rhinitis birch pollen long‐term phase III post‐treatment subcutaneous allergen immunotherapy |
| title | Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| title_full | Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| title_fullStr | Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| title_full_unstemmed | Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| title_short | Subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long‐term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| title_sort | subcutaneous birch pollen allergen immunotherapy with a depigmented polymerized extract shows only sustained and long term efficacy in a subgroup of monosensitized adults and adolescents with allergic rhinitis |
| topic | allergic rhinitis birch pollen long‐term phase III post‐treatment subcutaneous allergen immunotherapy |
| url | https://doi.org/10.1002/clt2.12185 |
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